NCT04370379CompletedPhase 1
A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of IBI302 in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Innovent Biologics (Suzhou) Co. Ltd.1 site in 1 country18 target enrollmentStarted: May 28, 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Ocular safety, assessed by BCVA, slitlamp examination, ophthalmoscopy, IOP, fundus photography
Study Overview
Brief Summary
This study is designed for multi-center, open-label, randomized, dose escalation phase I trial to evaluate the safety and tolerability of a multiple dose intravitreal injection of IBI302 in neovascular AMD patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inclusion criteria
- •Male or female patient ≥ 50 yrs. of age.
- •Active subfoveal or parafoveal CNV secondary to neovascular AMD.
- •Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
- •Exclusion criteria
- •Presence of uncontrolled glaucoma in the study eye (defined as IOP≥30mmHg despite the standardized treatment);
- •Presence of active intraocular or periocular inflammation or infection;
- •History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
- •Participated in any clinical study of any other drug within three months prior to enrollment, or attempted to participate in other drug trials during the study;
- •Diabetic patients have any of the following conditions:HbA1c>7.5% when screening;
Exclusion Criteria
- Not provided
Arms & Interventions
low dose of IBI302
Experimental
Intervention: IBI302 (the first dose level) (Drug)
high dose of IBI302
Experimental
Intervention: IBI302 (the second dose level) (Drug)
2mg aflibercept
Active Comparator
Intervention: Aflibercept (Drug)
Outcomes
Primary Outcomes
Ocular safety, assessed by BCVA, slitlamp examination, ophthalmoscopy, IOP, fundus photography
Time Frame: Baseline to Day140
Incidence of adverse events
Time Frame: Baseline to Day140
Secondary Outcomes
- Changes in central subfield thickness by OCT compared with baseline(Baseline to Day140)
- Changes in CNV characteristics and CNV area by FA compared with baseline(Baseline to Day140)
- Changes in BCVA compared with baseline(Baseline to Day140)
- the area under the curve at the time of 0-infinity of IBI302(Baseline to Day140)
- Positive rate of anti-drug antibody and neutralizing antibody of IBI302(Baseline to Day140)
- the area under the drug-time curve from 0 to time t of IBI302(Baseline to Day140)
- The peak concentration of IBI302(Baseline to Day140)
- The peak time of IBI302(Baseline to Day140)
- Clearance rate of IBI302(Baseline to Day140)
- Half-life of IBI302(Baseline to Day140)
- VEGF concentration(Baseline to Day140)
- Concentration of complement fragments(Baseline to Day140)
Investigators
Study Sites (1)
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